Sunday, September 21, 2008

Amoxycilin, Aciclovir and Heparin – Safe or not?

I picked up some Aciclovir from the local pharmacy today. Aciclovir is one of the three drugs made by Ranbaxy from India. Ranbaxy made headlines after it failed the USFDA's (US Food and Drug Administration) audit process. Should I give the Aciclovir to Princess of the House? I am not sure, so I rang my local pharmacy. The pharmacist I spoke to says there is no evidence to suggest Ranbaxy products in NZ are problematic.

Ministry Chief Advisor Public Health Dr Ashley Bloomfield says "there is no evidence that individual drugs have been affected and patients are advised they should continue taking them." To be really cynical - how does Dr Bloomfield know? Can he trace the origin and the compounds used by Ranbaxy and can be sure it is not sourced from China? Can he assure us there is no contamination in Aciclovir or the Amoxycilin?

I find it distressing Dr Bloomfield can be so certain when the audit process done by the US has failed the company. What can we do??? Is your child ill? Is your child being given Amoxycilin (an antibiotic) or Aciclovir (to treat cold sores)? Princess of the House’s best mate the one with Rapuzel-hair, slept here last night. She has had 2 doses of Amoxycilin since yesterday evening. Should her mom be worried too?

The US FDA has banned about 30 drugs made by Ranbaxy including Cipro (which Princess of the House is also on!) and cholesterol pill Zocor – citing poor quality at two of Ranbaxy’s factories. According to the Financial Times, “Ranbaxy’s latest troubles come only two months after the US Justice Department intensified legal action against the company, alleging adulteration of some of its products. The company has insisted the claims are “baseless”.

The USFDA last week criticised Ranbaxy for violations to ”good manufacturing practice”. It said it could not be sure that processing took place in sterile conditions, nor that there was protection against cross-contamination of pharmaceuticals

What should we do? My local pharmacist tells me there are other sources of Aciclovir (Pacific Pharmaceuticals), but that is not funded by Pharmac. I checked the box on our Cipro – it says “Marketed by Pacific Pharmaceuticals”. Good, do I feel safer?

Am I being paranoid now? Shouldn’t I be? What if Ranbaxy’s Amoxycilin is indeed substandard. Will NZ be scrambling (like the rest of the world will be) for fresh supplies? According to the Ministry of Health’s web info, about 400,000 Amoxycilin prescriptions are made a year; and a 160,000 prescriptions for Aciclovir.

I think I am going to be more paranoid than ever. Pretzel who commented on my blog led me to a site which lists stories of counterfeit products made by China. I felt sick in the stomach when I saw heparin on the list of counterfeits that have shown up in the world. Princess of the House was in hospital for 8 weeks and had many doses of heparin injected into her body. Heparin helps thin the blood to prevent clots.

Heparin is made from the intestines of slaughtered pigs. The mucous membrane from the intestines is collected and cooked, eventually producing a dry substance known as crude heparin.

Baxter suspended the production of heparin in multi-dose vials after four patients died in the US after high doses of heparin. There were also 350 reports of severe allergic reactions to heparin, with symptoms including a rapid drop in blood pressure, burning sensations, headaches, throat swelling and a shortness of breath.

According to the website (check it out yourself Business Action to Stop Counterfeiting and Piracy (BASCAP) contaminated heparin has been linked to 19 deaths in the US and hundreds of allergic reactions. The gist I got from reading the site was that Baxter, which has been buying active ingredients to make heparin, was being sold counterfeit by cowboy operators in China.

Baxter bought its heparin ingredient from China’s Changzhou SPL, a factory in the city of the same name. This facility is actually 55 per cent owned by Scientific Protein Laboratories (does this sound familiar - Sanlu and Fonterra??) which has another manufacturing site in Wisconsin, US. All this happened in April.

The US, Germany, France, Italy, Denmark, Switzerland and Japan have been reported to have pulled heparin products from the market due to the presence of contamination or as a precautionary measure after API links to China were made.

When I did more reading, I found that Australia's Therapeutic Goods Administration (TGA) too had discovered contamination in samples of heparin distributed by UK-based drug giant AstraZeneca. Other manufacturers of heparin are: Hospira and Pfizer. Australia’s drug watchdog TGA says: “AstraZeneca has since confirmed that its heparin API was sourced form China and it is in discussions with the TGA to recall the affected product as soon as possible. The firm also indicated that it is now evaluating its China supply chain.”

I checked NZ’s Ministry of Health’s website and found this statement: “So far, testing of the finished products being supplied to patients in New Zealand indicates that these products are free from contamination.” Should I rest assured? Are we relying on our own testing mechanisms or USFDA to do our job? Do we trust the drug maker’s supply chain?

What everyone should be asking of the Ministry of Health is: How many drugs do we import from NZ that have compounds made in China or India or Thailand or Cambodia etc? How do we know these compounds are safe for users in NZ? Is Pharmac’s funding warped in anyway? (If I don’t buy Ranbaxy’s Aciclovir, who else can I buy from??) Should NZ rely on the USFDA to do primary regulation/tests for us?

This is just the tip of the iceberg. Our logic must be, for now, to have some control over NZ’s own supply chain. We know we can’t trust big MNCs -- be they hotshot financial companies (like Merrill or Goldman or AIG) or big pharmas like Baxter or Astra Zeneca who do get duped by unethical Chinese merchants. I have stopped buying Made-in-China food. But the question is can I stop buying drugs with Chinese ingredients or ingredients from unknown sources.

Your concern is not baseless. I'm a student doctor undergoing training in one of the MoH hospitals. There is a rising concern among doctors regarding the effectiveness of certain generic drugs; drug with similar chemical structure but is a lot cheaper than its counterpart.

Ranbaxy is a company that manufactures such drugs. However the concern over here is not contamination of those drugs but rather the dosage of drugs in each pill/tablet is lower than what's supposed to be.

There are few instances when medication doesn't work. Thus doctors here opt to use the same drug but manufactured by different company.

But please do not quote me saying this. There are no local studies/investigation done to prove this claim. For now, it is still a gut feeling.

Maybe what you can do for now is to buy medication made by different companies. Not so much problem with amoxycilin, they're affordable. Aciclovir on the other hand is pretty expensive.

I don't know whether you remember me... Im Mior Azhar and used to write for Computimes (with Dan E and Derrik Khoo those brothers) but I always came down to first floor to do my story...I came here via Rocky's. I am at Malaysian Business now... with Charles Raj as my boss.Good to finally locate you

i read rocky's brew. he said something about childhood cancer. I'm sorry to hear abt your princess of the house. if it's anything to do with cancer, do some research on artemisinin and make your own conclusions. hope it helps.

Hello,I live in Malaysia and are a cancer patient myself.(stage IV livercancer spread from colon)Have a look at serai (lemon grass) as inhibitor.Another one but hard to get (but damned cheap) is caesium chloride.Both inhibit the intake of sugars by the cancer cells.I just finished 12 chemo's and my liver is clear now.Albert(bohe@streamyx.com)

You mentioned...however the concern over here is not contamination of those drugs but rather the dosage of drugs in each pill/tablet is lower than what's supposed to be.

Any info along these lines regarding Keppra the drug to control epileptic seizures? I know someone close who is taking it and still has the seizures on a fairly regular basis when they should have been under total control. Could the dosage of the drug be less than it should be?

I'm sorry I don't have that info. But Keppra is a new drug and I don't think the generic ones are made yet.

However, again I stress not to quote me. In this case, I suggest not to query the dosage content of the medication. Epilepsy control is tricky. A lot of things can set it off balance. Change of medication, stress and regularity of the meds taken to name some.

Please bring the person for a check up and get a qualified medical opinion.

Yoke Har, I apologize for using this space for unrelated discussion ya.

I tried to finish what you want to say but couldn't , I just cannot imagine parents trying to feed their child with antibiotic bcos I myself & my family have bad experiences with antibiotics. We have not touch antibiotics for years.

I suggest you take a look at the probiotics instead, there is an pdf on my blog [http://enzymo.wordpress.com/%E7%9F%A5%E8%AF%86%E5%AE%9D%E5%BA%93-knowledge-treasure/], or you can get this book [The Probiotics Revolution - Huffnagle,Dr Gary & Wernick,Sarah]p/s: Sorry for my language, I just hate antibiotic

Hi Yoke Har, U might remember Hafifi Hafidz. Our son was born with congenital heart and without a spleen. Has gone thru 2 major operations and recently we were told another one is needed. While going thru all these, Hafifi was diagnosed with cancer, battling with chemo and radiotherapy. We have something to share with you. Do email me at azlinib@yahoo. com. Take care and b strong.

Hi Albert,My mother has colon cancer and is undergoing chemo. Appreciate if you can tell me how much and in what form to take the serai (lemon grass) as inhibitor?And where can I get the caesium chloride?

Rocky - good to know Malaysia has cattle source. My question remains, do big pharmas have control over their supply chains? I think there is a failure in the loop somehow or the likes of Baxter would not have gotten into the trouble they did with their heparin.

Enzymo - thanks for your suggestions on probiotics. Princess is in remission. But managing colingitis (infection of the bile ducts) is the current problem. Princess gets massive doses of antibiotics -- all sorts -- name it, and we have had it..to treat a broad spectrum of bugs in the system. Will check out your pdf..thanks!

Azman: Re Aciclovir - I checked with the local pharmacist here, they say only the Ranbaxy version is funded. I think if there is a real problem (if desperate and needed), we will pay for it. It is a short-term drug unlike Sirolimus, which is a long-term one. But so far - Sirolimus hasn't come under scrutiny.

And not to worry about discussions on other drugs. Esp Keppra, I have a friend whose daughter has epileptic fits too...looking for the perfect cure..